What's New in the Guidelines?

Recommendations Regarding Use of Dolutegravir in Adults and Adolescents with HIV who are Pregnant or Of Child Bearing Potential, a joint statement from the HHS Antiretroviral Guideline Panels, was released on May 30, 2018.

Based on input from the community, the Adult and Adolescent Guidelines have been updated to include People-First Language. People-First Language is a way of reducing stigma and showing respect for individuals who are living with HIV by focusing on the person instead of the disease (e.g., where the Guidelines might have said "HIV-infected person" in the past, this will now be written as "person with HIV"). The use of People-First Language may also assist as a strategy for retention-in-care measures.

Since the last revision, longer-term safety data have clarified the relative advantages of tenofovir alafenamide (TAF) and tenofovir disoproxil fumarate (TDF). TAF has less bone and kidney toxicity, and is therefore particularly advantageous in people at risk for those conditions; TDF is associated with lower lipid levels. Safety, cost, and access are among the factors to consider when choosing between TAF and TDF.

Updates have been made throughout the section with new safety and clinical trial data.

Under the section on Other Antiretroviral Regimens for Initial Therapy When Abacavir, Tenofovir Alafenamide, and Tenofovir Disoproxil Fumarate Cannot Be Used, a new subsection has been added to discuss ongoing clinical trials of various treatment strategies.

The Panel on Antiretroviral Guidelines for Adults and Adolescents (the Panel) emphasizes that monotherapy with any antiretroviral (ARV) drug should not be used due to increased risk of virologic failure and drug resistance.

The Panel no longer prohibits the use of efavirenz during the first trimester of pregnancy.

The Panel emphasizes that using PI or INSTI monotherapy as maintenance therapy has been associated with high rates of virologic failure and is therefore not recommended.

The Panel also notes that, traditionally, the Guidelines have recommended starting ART-naive patients on a regimen consisting of at least three active drugs. However, several studies have now noted that persons with HIV who have sustained viral suppression with no drug resistance may be maintained on regimens including only two active drugs. Results from clinical trials using two-drug maintenance therapy are discussed in this section.

The section also stresses that when considering a regimen switch in a person with HBV/HIV coinfection, it is important to maintain drugs active against HBV infection in the new regimen.

Clinical trial data involving several ARV combinations that are currently under investigation are discussed in this section.

Several ARV combinations that are not recommended for use in maintenance therapy are also included in this section.

The Panel recommends that individuals with chronic HBV infection should receive treatment for HBV with nucleoside reverse transcriptase inhibitors (NRTIs) that are active against both HIV and HBV before starting HCV therapy.

For the HCV section, interactions between new HCV direct-acting agents and ARV drugs have been added to Table 12.

The previous Adherence to Antiretroviral Therapy section has been extensively revised to not only include adherence to therapy, but also adherence to the entire HIV care continuum. As such, the title of this section has been changed to Adherence to the Continuum of Care.

The section stresses the importance of clinicians working collaboratively with a multidisciplinary team to understand barriers to adherence to the continuum, as well as working with patients to overcome those barriers.

New evidence-based interventions and best practices to improve adherence are summarized.

Given their high genetic barriers to resistance, dolutegravir and boosted darunavir are mentioned as medications to consider in persons with proven problems with adherence.

The old Table 18 (Drugs That Should Not Be Used With Antiretroviral Agents) has been removed from this document. Drugs that are contraindicated or not recommended for use are now all included in the individual ARV drug class tables.

Throughout the tables, a number of drug classes have been added or expanded, including oral anticoagulants, new oral hypoglycemic agents, and hormonal therapy for menopausal management and gender affirmation.